Department of Health and Human Services July 20, 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that published in the Federal Register on May 21, 2018. In that document, FDA requested comments on the draft revised guidance for industry (GFI) #197 entitled ``Documenting Electronic Data Files and Statistical Analysis Programs.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Surveillance of Nonfatal Injuries Among On-Duty Law Enforcement Officers.'' The purpose of this project is to collect follow-back telephone interview data from injured and exposed law enforcement officers treated in emergency departments (EDs) and produce a descriptive summary of these injuries and exposures.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Knowledge, Attitudes, and Practices of US Large Animal Veterinarians Concerning Common Veterinary Infection Control Measures When Working with Animal Obstetric Cases. The goals of this survey are to better describe veterinarians' current knowledge of zoonotic infectious diseases that cause abortion in large animals, determine common veterinary infection control practices when working up obstetric cases, and identify common barriers to personal protective equipment use.

The Food and Drug Administration (FDA, Agency, or we) is reopening the comment period for the ``Metered Dose Inhaler and Dry Powder Inhaler Drug ProductsQuality Considerations; Draft Guidance for Industry,'' published in the Federal Register of April 19, 2018. FDA is reopening the comment period to allow interested persons additional time to submit comments.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Notice is hereby given of the meeting on August 2, 2018, of the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Advisory Council (SAMHSA NAC).